Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding (BAIT): A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This pilot study aims to gather preliminary evidence on how different hemoglobin levels impact blood biomarkers related to bleeding. The feasibility of conducting a future larger clinical trial will also be assessed. Red blood cell transfusions are part of the standard of care for patients with leukemia. This study evaluates two transfusion strategies: one that maintains hemoglobin levels above the standard-of-care threshold, reflecting current routine practice; and another that maintains hemoglobin levels above 110 g/L, which is closer to the normal hemoglobin range. The normal hemoglobin range is 120-160 g/L for females and 140-180 g/L for males. Raising hemoglobin levels closer to normal values may reduce bleeding risk.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥18 years old.

• Inpatient

• Diagnosis of acute myeloid leukemia or acute lymphocytic leukemia.

• Less than 5 days have elapsed since the start of induction chemotherapy treatment.

• Hemoglobin at enrolment is under 130 g/L.

Locations
Other Locations
Canada
Juravinski Hospital
RECRUITING
Hamilton
Contact Information
Primary
Dimpy Modi
modid1@mcmaster.ca
905-525-9140
Time Frame
Start Date: 2025-04-11
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 60
Treatments
Experimental: RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/LL
Participants randomized to this arm will be assigned to a liberal RBC transfusion strategy to maintain a hemoglobin level of at least 110 g/L.
No_intervention: Standard-of-care RBC transfusion strategy
Participants randomized to this arm will be assigned to a restrictive RBC transfusion strategy of standard-of-care, which is typically to maintain a hemoglobin level of at least 70-80 g/L.
Related Therapeutic Areas
Sponsors
Leads: Donald Arnold

This content was sourced from clinicaltrials.gov